Brachial Artery t-PA Release in Heart Transplant Recipients (P1A3C)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00780637
Recruitment Status : Withdrawn (Bradykinin Shortage, SCCOR expired prior to BK availability, lack of enrollment.)
First Posted : October 27, 2008
Last Update Posted : July 15, 2016
Information provided by (Responsible Party):
James Muldowney, Vanderbilt University

Brief Summary:

Bradykinin stimulates t-PA release from intact vessels, but not from endothelial cells in culture. It has been proposed that the nerves of blood vessels are the source of bradykinin stimulated t-PA release. In order tho test this hypothesis, we intend to infuse bradykinin into the brachial (arm) artery and the coronary arteries of heart transplant recipients and control subjects. This is because heart transplant recipients do not have nerves to their coronary arteries.

This protocol studies the effects of bradykinin on t-PA release in the forearm of transplant recipients. The brachial artery has intact nerves.

Separate protocols address coronary artery infusions in healthy subjects and transplant recipients and forearm infusions in healthy subjects.

Condition or disease Intervention/treatment Phase
Heart Transplantation Drug: Bradykinin Not Applicable

Vanderbilt University has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.  

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Characterization of Brachial Arterial t-PA Release, Vasodilator Function, and Vascular Compliance and Correlation With Fibrinolytic Balance, Oxidative Stress, and Inflammation Measures in Heart Transplant Recipients (SCCOR Project 1, Aim 3C)
Study Start Date : October 2008
Actual Primary Completion Date : January 2011
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Bradykinin
Patients receive 0, 10, 20, and 40 ng/min/100cc forearm volume of intrabrachial bradykinin, for 5 minutes at each dose. Forearm blood flow will be measured by strain gauge plethysmography, blood samples will be obtained to measure t-PA, PAI-1 at each dose. FMD and Radial artery tonometry will also be performed under resting conditions.
Drug: Bradykinin
Patients receive 0, 10, 20, and 40 ng/100cc forearm volume/min of bradykinin intrabrachial.

Primary Outcome Measures :
  1. Peak t-PA release [ Time Frame: Single Study Visit ]

Secondary Outcome Measures :
  1. t-PA release at various doses [ Time Frame: Single Study Visit ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion criteria:

  1. Adults 18 years and greater who have undergone heart transplantation
  2. Healthy

Exclusion criteria:

  1. PVC < 30
  2. Hypertensive subjects on ACE inhibitors
  3. Pregnant or nursing mothers
  4. Diabetic with HbA1C > 7.5 or stigmata of end organ damage (neuropathy, retinopathy, nephropathy, cardiomyopathy)
  5. Cholesterol > 30 mg/dL above NCEP accepted level based on cardiac risk.
  6. Triglycerides > 200
  7. Previously diagnosed obstructive coronary artery disease
  8. Renal insufficiency (Creatinine ≥ 1.5 mg/dl)
  9. History of cerebrovascular disease
  10. Any chronic inflammatory disease (rheumatologic, inflammatory bowel disease, etc)
  11. Uncontrolled Stage 2 Hypertension (160/100 mmHg), or end organ damage due to hypertension (left ventricular hypertrophy, atrial fibrillation, hematuria, renal insufficiency, prior cerebrovascular disease).
  12. Angiotensin converting enzyme inhibitor use
  13. Coagulopathy (INR ≥ 1.5, PTT ≥ 150% of control)
  14. Peripheral Vascular Disease
  15. Other chronic medical illnesses at the discretion of the investigators

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00780637

United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
Principal Investigator: James AS Muldowney, MD Vanderbilt University Medical Center

Responsible Party: James Muldowney, Assistant Professor of Medicine, Vanderbilt University Identifier: NCT00780637     History of Changes
Other Study ID Numbers: 070517
First Posted: October 27, 2008    Key Record Dates
Last Update Posted: July 15, 2016
Last Verified: July 2016

Keywords provided by James Muldowney, Vanderbilt University:
Heart Transplant
Endothelial Function
Transplant recipients at baseline

Additional relevant MeSH terms:
Vasodilator Agents
Cysteine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action